FDA 510(k)

CORE-SPORT

K-Number: K220081 · 2022-09-28

Decision Date2022-09-28

Product CodeOTJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

CORE-SPORT is the device name listed in this FDA 510(k) record. The listed applicant is Incore Co., Ltd.. It received FDA 510(k) clearance on 2022-09-28 under 510(k) number K220081. The device is classified under product code OTJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORE-SPORT?

CORE-SPORT is a medical device that received FDA 510(k) clearance on 2022-09-28. The listed applicant is Incore Co., Ltd.. The 510(k) number is K220081.

When did CORE-SPORT receive FDA 510(k) clearance?

CORE-SPORT received FDA 510(k) clearance on 2022-09-28, under 510(k) number K220081.

Who is the listed applicant for CORE-SPORT?

The FDA 510(k) record lists Incore Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORE-SPORT?

The FDA product code for CORE-SPORT is OTJ.

Other records listing Incore Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232216Hemoblock_S (Prescription); Hemoblock_S (OTC)K221054CORE-INJECTOR K220846CORE-SNARE K213338CORE-CLIP K211148CORE-Trocar

Related Devices (Code: OTJ)

K232062Uni-portDalim Medical Corp.K202688AFS Medical Sterile Single-Use Access Port SystemAfs Medical Co. , Ltd.K160797FMX314 Surgical PlatformFortimedix Surgical B.V.K152598Endo KeeperNelis

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.